UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046841 |
|---|---|
| Receipt number | R000053441 |
| Scientific Title | Multi-omics cohort analysis and biobank construction in Japanese patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/04/20 18:51:21 |
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Basic information
Public title
Multi-omics cohort analysis and biobank construction in Japanese patients with inflammatory bowel disease
Acronym
IBD-MOCHA
Scientific Title
Multi-omics cohort analysis and biobank construction in Japanese patients with inflammatory bowel disease
Scientific Title:Acronym
IBD-MOCHA
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Crohn's disease
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Factors involved in the development and prognosis of inflammatory bowel disease
Basic objectives2
Others
Basic objectives -Others
Omics analysis to search for factors involved in the above and construction of a biobank of specimens for this purpose.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic factors involved in pathogenesis
Key secondary outcomes
Serum proteins, gut microbiota, and genetic background related to prognosis and pathology
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inflammatory bowel disease (Crohn's disease, ulcerative colitis, unclassifiable enteritis) or suspected cases
Key exclusion criteria
Cases in which the cause of enteritis symptoms is obvious (infectious enteritis, ischemic enteritis, diverticulitis, etc.)
Other cases that the attending physician considers inappropriate
Target sample size
5500
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo Aoba, Sendai
TEL
0227177171
ykakuta@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo Aoba, Sendai
TEL
0227177171
Homepage URL
ykakuta@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo Aoba, Sendai
Tel
022-728-4105
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Course of treatment, medical history, etc.
Management information
Registered date
| 2022 | Year | 02 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053441
